Complete this section only if you require an XML document to register your trial with ClinicalTrials.gov.
The Responsible Party can be either a sponsor, principal investigator (PI), or sponsor/investigator. The term "responsible party" is either of the following:
For further elaboration on the definition of these roles with respect to responsible party, refer to http://prsinfo.clinicaltrials.gov/ElaborationsOnDefinitions.pdf. |
The fields displayed in the Sponsor/Responsible Party section depend on your selection of the Responsible Party role:
Screenshot TBD. |
In the Sponsor/Responsible Party section, select or enter the appropriate information in the text fields and drop-down lists. The following table describes the fields. An asterisk (*) indicates a required field.
Field Label | Description/Instructions |
---|---|
Sponsor | Click Look Up Sponsor and search for the organization as per the instructions in Looking Up Registered Organizations. |
Responsible Party | Indicate the party who is responsible for the trial. Select one of the following options:
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Investigator* | If the Responsible Party is the Principal Investigator, you can not change the person's name. If the Responsible Party is the Sponsor-Investigator, you can change the person's name. To do so, click Look Up Sponsor, and follow the instructions in Looking Up Registered Persons. |
Investigator Title* | The system populates this field. Enter a new title in the field provided if other than Principal Investigator. |
Investigator Affiliation* | If the Responsible Party is the Principal Investigator, you can change the affiliated organization. To do so, click Look Up Organization, and follow the instructions in Looking Up Registered Organizations. If the Responsible Party is the Sponsor-Investigator, you can not change the affiliated organization. |